(363 days)
No
The description focuses on data transmission, storage, and display, with no mention of AI or ML algorithms for analysis or interpretation.
No.
The SomnoTraxx System collects and transmits usage and therapeutic information from CPAP systems but does not provide direct treatment itself. It augments follow-up care by providing data to healthcare professionals. The therapeutic devices are the CPAP systems with which SomnoTraxx is used.
No
The SomnoTraxx System is described as a system for wireless transmission and display of usage and therapeutic information from CPAP devices, augmenting standard follow-up care. It is explicitly stated that it is "not intended to provide automated treatment decisions nor to be used as a substitute for a competent healthcare professional's judgment." Its purpose is to facilitate the retrieval and display of already stored data from CPAP devices for review by a healthcare provider, rather than to make a diagnosis itself.
No
The device description explicitly states that the SomnoTraxx System is comprised of two distinct components: the ResTrax™ (a wireless module that attaches to the CPAP flow generator) and the Server System (software modules). The ResTrax™ is a hardware component.
Based on the provided text, the SomnoTraxx System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The SomnoTraxx System's intended use is to transmit and display usage and therapeutic information from a CPAP machine, which is a medical device used for treating sleep apnea. It does not analyze any biological samples.
- The description focuses on data transmission and display. The system is comprised of a wireless module and a server system designed to retrieve, store, and display data from the CPAP flow generator. This is a data management and communication function, not an in vitro diagnostic test.
- The intended use is to augment standard follow-up care. This implies the system provides information to support clinical decisions based on the patient's use of the CPAP device, not to diagnose or monitor a condition through laboratory analysis.
Therefore, the SomnoTraxx System falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SomnoTraxx System is intended to augment the standard follow-up care of patients diagnosed with obstructive sleep apnea by providing wireless transmission and display of usage and therapeutic information. It is intended for home use only in conjunction with ResMed S7 Elite and AutoSet Spirit CPAP Systems Positive Airway Pressure flow generators.
SomnoTraxx System is not intended to provide automated treatment decisions nor to be used as a substitute for a competent healthcare professional's judgment.
All patients' medical diagnosis and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.
The S7 Elite and AutoSet Spirit CPAP Systems are indicated for the treatment of obstructive sleep apnea (OSA) in adult patients.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The S7™ Elite (K013909) and AutoSet® Spirit™ (K013843) CPAP Systems are microprocessor controlled blower-based systems that generate Continuous Positive Airway Pressure (CPAP) from 4-20 cmH2O as required to maintain an "air splint" for effective treatment of Obstructive Sleep Apnea (OSA).
The system includes the flow generator, patient tubing and a mask (patient interface). For additional humidification, several humicifiers, including the integrated HuMDARE 2i, are designed to be compatible with the flow generators. AutoScan software allows viewing of flow-generator stored treatment data via a PC, transmitting the data using a direct connection or a modem.
The SomnoTraxx™ System is designed to be used with ResMed's S7™ Elite and AutoSet Spirit™ CPAP The common raise " yetner retrieval and display of stored information from the flow generators to the clinician, via wireless transmission and web-based access. Access to the data is limited to subscribers of the system. There is no patient access to the system.
The SomnoTraxx™ System is comprised of two distinct components, the ResTrax™ and the Server System. Data are extracted from the flow generator, transmitted via a wireless network, stored in a database, transmitted via the Internet and displayed for review by a healthcare provider. Both components must be present in order for the SomnoTraxx™ System to function.
ResTraxx™ ~ResTrax™ is an optional wireless module designed to attach to a ResMed S7™ Elite or AutoSet® Spirit™ flow generator using a docking mechanism allows the device to be electrically connected via the existing 15-pin expansion port located at the rear of the flow generator. When attached, the ResTrax™ can automatically collect usage and therapeutic information stored within the flow generator's memory.
The ResTrax™ sends and receives information utilizing existing messaging networks providing wireless coverage to large portions of the US population.
Server System – The Server System consists of several functional software modules that are designed to retrieve information from flow generators through the ResTrax™ and a wireless messaging network, store the information in a database and provide a secure interface into the system allowing users (not patients) to schedule information retrieval and view the results.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Home use only in conjunction with ResMed S7 Elite and AutoSet Spirit CPAP Systems Positive Airway Pressure flow generators. Data access is limited to subscribers of the system (clinicians/users, not patients).
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design Verification and Valication were performed on the S7 Elite™ & AutoSet® Spirit™ CPAP Systems with SomnoTraxx™ System, in accordance with the risk analysis and product requirements. All tests with ourned the product meets the acceptance criteria. ResMed has determined that the modified design has oonlined the product mode effectiveness of the device. The S7™ Elite& AutoSet® Spirit™ CPAP system with SomnoTraxx™ System is equivalent to the S7™ Elite& AutoSet® Spirit™ CPAP system without SomnoTraxx™System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K013909, K013843, K014025, K020184
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows a handwritten text string that appears to be an alphanumeric code or identifier. The code is "K030797" and is written in a simple, slightly tilted manner. The handwriting is clear and legible, with each character distinctly formed.
.
510(k) Summary
MAR 1 0 2004
S7™ Elite and AutoSet® Spirit™ CPAP Systems with SomnoTraxx™ System™
| Date Prepared | November 21, 2003 |
|---|---|
| Official Contact | David D'Cruz |
| VP, US Clinical and Regulatory Affairs | |
| ResMed Corp. | |
| 14040 Danielson St | |
| Poway, CA 92064 | |
| (858) 746-2238 | |
| Classification Reference | 21 CFR 868.5905 |
| Product Code | BZD - Non-Continuous Ventilator |
| Common/Usual Name | CPAP System |
| Proprietary Name | S7™ Elite and AutoSet® Spirit™ CPAP Systems with |
| SomnoTraxx™ System™ | |
| Predicate Device(s) | ResMed, S7™ Elite CPAP System (K013909) |
| ResMed, AutoSet® Spirit™ CPAP System (K013843) | |
| HomMed Sentry III Patient Monitoring System with Card Reader | |
| K014025 | |
| HomMed Central Station K020184 | |
| Reason for Submission | Modified design - additional accessory |
| Indications for Use | The SomnoTraxx System is intended to augment the standard follow- |
| up care of patients diagnosed with obstructive sleep apnea by providing | |
| wireless transmission and display of usage and therapeutic information. | |
| It is intended for home use only in conjunction with ResMed S7 Elite | |
| and AutoSet Spirit CPAP Systems Positive Airway Pressure flow | |
| generators. | |
| SomnoTraxx System is not intended to provide automated treatment | |
| decisions nor to be used as a substitute for a competent healthcare | |
| professional's judgment. | |
| All patients' medical diagnosis and treatment are to be performed under | |
| the supervision and oversight of an appropriate healthcare professional. | |
| The S7 Elite and AutoSet Spirit CPAP Systems are indicated for the | |
| treatment of obstructive sleep apnea (OSA) in adult patients. |
Last saved: 11/23/2003 11:43 PM
.
Page 9 of 16
,
1
Description
bescription
The S7™ Elite (K013909) and AutoSet® Spirit™ (K013843) CPAP Systems are microprocessor controlled blower-based systems that generate Continuous Positive Airway Pressure (CPAP) from 4-20 cmH2O as required to maintain an "air splint" for effective treatment of Obstructive Sleep Apnea (OSA).
The system includes the flow generator, patient tubing and a mask (patient interface). For additional humidification, several humicifiers, including the integrated HuMDARE 2i, are designed to be compatible with the flow generators. AutoScan software allows viewing of flow-generator stored treatment data via a PC, transmitting the data using a direct connection or a modem.
Description of Device Modifications
The SomnoTraxx™ System is designed to be used with ResMed's S7™ Elite and AutoSet Spirit™ CPAP The common raise " yetner retrieval and display of stored information from the flow generators to the clinician, via wireless transmission and web-based access. Access to the data is limited to subscribers of the system. There is no patient access to the system.
The SomnoTraxx™ System is comprised of two distinct components, the ResTrax™ and the Server System. Data are extracted from the flow generator, transmitted via a wireless network, stored in a database, transmitted via the Internet and displayed for review by a healthcare provider. Both components must be present in order for the SomnoTraxx™ System to function.
ResTraxx™ ~ResTraxx™ is an optional wireless module designed to attach to a ResMed S7™ Elite or AutoSet® Spirit™ flow generator using a docking mechanism allows the device to be electrically connected via the existing 15-pin expansion port located at the rear of the flow generator. When attached, the ResTrax™ can automatically collect usage and therapeutic information stored within the flow generator's memory.
The ResTraxx™ sends and receives information utilizing existing messaging networks providing wireless coverage to large portions of the US population.
Server System – The Server System consists of several functional software modules that are designed to retrieve information from flow generators through the ResTraxx™ and a wireless messaging network, store the information in a database and provide a secure interface into the system allowing users (not patients) to schedule information retrieval and view the results.
Substantial Equivalence
The modified device has the following similarities to the previously cleared devices:
- Similar intended use ↓
- Similar operating principles .
- . Similar technologies
- Same manufacturing processes .
Design Verification and Valication were performed on the S7 Elite™ & AutoSet® Spirit™ CPAP Systems with SomnoTraxx™ System, in accordance with the risk analysis and product requirements. All tests with ourned the product meets the acceptance criteria. ResMed has determined that the modified design has oonlined the product mode effectiveness of the device. The S7™ Elite& AutoSet® Spirit™ CPAP system with SomnoTraxx™ System is equivalent to the S7™ Elite& AutoSet® Spirit™ CPAP system without SomnoTraxx™System.
Page 10 of 16
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three flowing lines representing the body and arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 0 2004
Mr. David D'Cruz ResMed Corporation VP. Regulatory Affairs 14040 Danielson Street Poway, California 92064-6857
Re: K030797
Trade/Device Name: S7 Elite and AutoSet Spirit CPAP Systems with Somno Traxx System Regulation Number: 868.5905 Regulation Name: Non-Continuous Ventilator Regulatory Class: Il Product Code: BZD Dated: January 8, 2004 Received: January 12, 2004
Dear Mr. D'Cruz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I·DA has made a determination that your device complies with other requirements
3
Page 2 - Mr. David D'Cruz
of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
Carls
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use (Revised)
K030797 510(k) Number (if known):
Device Name
S7™ Elite and AutoSet® Spirit™ CPAP Systems with SomnoTraxx™ System
Indications for Use:
The SomnoTraxx System is intended to augment the standard follow-up care of patients diagnosed with obstructive sleep apnea by providing wireless transmission and display of usage and therapeutic information. It is intended for home use only in conjunction with ReslMed S7 Elite and AutoSet Spirit CPAP Systems Positive Airway Pressure flow generators.
SomnoTraxx System is not interided to provide automated treatment decisions nor to be used as a substitute for a competent healthcare professional's judgment.
All patients' medical diagnosis and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.
The S7 Elite and AutoSet Spirit CPAP Systems are indicated for the treatment of obstructive sleep apnea (OSA) in adult patients.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Optional (Format 1.2.06)
$
(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, De
510(k) Number
Last saved: 11/23/2003 11:43 PM
Page 8 of 16
(Optional Format 1-2-96)